Biologics and Biosimilars: Regulatory Aspects(Pre-Master's) (RAQA)

Biologics and Biosimilars: Regulatory Aspects (Pre-Master's)

We offer two certificates in biologics and biosimilars.  This Pre-Master's Certificate places a greater emphasis on regulatory aspects related to biologics and biosimilars. 

The Certificate in Biologics and Biosimilars: Manufacturing provides a broad overview of the technical aspects of biologics manufacturing.

What regulatory issues are unique to biologics and biosimilar drug manufacturers? What are the clinical, manufacturing, regulatory, and strategic issues that challenge the path to global commercialization of a biological product? What are the current regulatory and technical/scientific issues involved in developing biological products in major ICH regions? What principles guide the development of biosimilar drugs, and how does biosimilar development differ from innovator drug development? How do biologics and biosimilars differ from chemically synthesized drugs?  What analytical methods are used to characterize biologics and how does analytical testing differ from small molecule testing? What Quality by Design principles relate to development, manufacturing, and testing of biologics? Explore these issues as you pursue the Certificate in Biologics and Biosimilars: Regulatory Aspects.

This five course certificate delves into the requirements of major ICH markets for biologics and biosimilar products. The certificate builds a strong foundation in the biologics and biosimilar regulatory landscape. The courses also expose students to key trends and controversies facing the biologics and biosimilar industry. enables students to become fluent in the methods used in the discovery of biopharmaceutical products, including materials sourcing and testing requirements. Technologies and unique considerations associated with the manufacture of biopharmaceutical products are discussed.

Students must complete three required courses:

  • Drug Development (RAQA 5459)
  • Biologics/Biosimilars: A Regulatory Overview (RAQA 5515)
  • Global CMCs – Biopharmaceuticals and Other Biologics (RAQA 5577)

Two electives from:

  • Production of Sterile Products (RAQA 5492)
  • Regulatory eSubmissions (RAQA 5514)
  • Clinical Drug Safety and Pharmacovigilance (RAQA 5538) OR RAQA 5571)
  • Special Topics in RAQA - Current Trends in Clinical Trials (RAQA 5560)
  • Post-Marketing Safety Surveillance (RAQA 5571) OR RAQA 5538
  • Vaccines: RA and QA Issues (RAQA 5572)

Transfer credits are not accepted towards Temple’s certificate programs. 

Brochure - Certificate in Biosimilars and Biologics: Regulatory Aspects

How to Receive the Certificate when you've completed the courses.

Submit the following items to the RAQA Office (hard copy only).

1. Application 

2. Photocopies of your undergraduate and graduate transcripts.

3. A transcript from Temple's Banner system of courses taken in the RAQA program.

4. Notice of Completion

All materials must be received by the stipulated deadlines (January 15 for February issuance; May 15 for June issuance; and August 20 for September issuance). Sorry, but if you miss the deadline, you will have to wait until the next time certificates are issued. Certificates will be mailed to your home in late February, late June, or late September.